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Arrowhead Pharmaceuticals develops and commercializes RNA interference medicines that silence genes associated with intractable diseases. The company’s TRiM™ platform is used to design targeted RNAi therapeutics for tissues including liver, lung, muscle, adipose and central nervous system tissue.
Recurring ARWR news covers REDEMPLO® (plozasiran), an siRNA medicine approved in the United States and Australia as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. Company updates also address plozasiran data across hypertriglyceridemia, regulatory actions in additional geographies, pricing and market-access strategy, fiscal results, investor events, and clinical or partnering developments involving programs such as ARO-PNPLA3, ARO-INHBE and ARO-ALK7.
Horizon Therapeutics plc (Nasdaq: HZNP) announced the dosing of the first subject in a Phase 1 clinical trial for HZN-457, a small interfering RNA designed to treat gout by silencing liver xanthine dehydrogenase. This trial aims to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in up to 56 healthy volunteers. Gout affects over 9 million patients in the U.S., with many inadequately treated by current therapies. HZN-457 aims to lower uric acid levels effectively, potentially improving patient outcomes. The development is part of a collaboration with Arrowhead Pharmaceuticals (Nasdaq: ARWR).
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has received a $15 million milestone payment from Horizon Therapeutics (NASDAQ: HZNP) following the enrollment of the first subject in a Phase 1 clinical trial for HZN-457, aimed at treating gout. This candidate, previously known as ARO-XDH, targets liver xanthine dehydrogenase to lower uric acid levels. The study will enroll 56 healthy volunteers to assess safety, tolerability, and pharmacokinetics. The collaboration with Horizon is pivotal in advancing innovative treatments for the over 9 million gout patients in the U.S.
Arrowhead Pharmaceuticals reported fiscal year 2022 results, achieving $243.2 million in revenue, up from $138.3 million in 2021. The company incurred a net loss of $172.7 million or $1.67 per diluted share. Operating expenses rose to $421.7 million compared to $287.3 million the prior year. Despite financial challenges, significant progress was made in clinical trials, with promising interim data on ARO-APOC3 and ARO-ANG3. The balance sheet was bolstered by a $250 million royalty sale and potential future earnings from Amgen.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will hold a webcast and conference call on November 28, 2022, at 4:30 p.m. ET to discuss its financial results for the fiscal year ending September 30, 2022. Investors can access the live audio via the company’s website, with a replay available two hours post-call. Arrowhead focuses on developing RNA interference therapies targeting intractable diseases.
Arrowhead Pharmaceuticals has announced that Royalty Pharma has acquired a royalty interest in Amgen's olpasiran for $250 million upfront, plus up to $160 million in additional payments based on milestones. Olpasiran, developed for cardiovascular disease treatment, is approaching Phase 3 trials. Arrowhead retains rights to $400 million in milestone payments related to Amgen's development of olpasiran. This agreement reinforces the potential of olpasiran and supports Arrowhead's investment in its RNAi therapeutic pipeline.
Arrowhead Pharmaceuticals presented new clinical data on RNAi-based therapies ARO-APOC3, ARO-ANG3, and olpasiran at the AHA Scientific Sessions 2022. ARO-APOC3 showed significant decreases in triglycerides by 86% and increases in HDL-C by 99%. ARO-ANG3 reduced triglycerides by 59% and LDL-C by 32%, while olpasiran decreased lipoprotein(a) levels by over 95% in ASCVD patients. The company plans to discuss these findings and its future plans in a virtual event on November 9, 2022.
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced on October 4, 2022, the approval of inducement grants for 39 new employees, totaling up to 117,500 restricted stock units. This includes 30,000 restricted stock units awarded to Peter Carignan, the new vice president of clinical operations. The grants, which fall under NASDAQ Listing Rules, are outside existing shareholder-approved equity incentive plans and will vest over four years.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will present interim clinical data on ARO-APOC3 and ARO-ANG3 at the American Heart Association Scientific Sessions 2022 in Chicago, from November 5-7, 2022. The SHASTA-2 and ARCHES-2 Phase 2 studies focus on patients with severe hypertriglyceridemia and mixed dyslipidemia, respectively. A virtual investor event is scheduled for November 9, 2022, to discuss these findings and future developments. Full data from ARCHES-2 is expected in the first half of 2023.
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) will participate in several upcoming events in September 2022. Key presentations include:
- ERS International Congress: September 4-6, 2022, by Erik Bush on MMP7 gene silencing.
- Wells Fargo Healthcare Conference: September 7-9, 2022, investor meetings with Vincent Anzalone.
- H.C. Wainwright Global Investment Conference: September 12-14, 2022, fireside chat by Christopher Anzalone.
- Baird Global Healthcare Conference: September 13-14, 2022, also featuring Christopher Anzalone.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has submitted an application to commence a Phase 1/2a clinical trial for ARO-MMP7, an investigational RNA interference therapeutic targeting matrix metalloproteinase 7 (MMP7) for idiopathic pulmonary fibrosis (IPF). The trial aims to assess safety, tolerability, and pharmacokinetics in healthy volunteers and IPF patients. This initiative expands Arrowhead's clinical pipeline, which includes other lung disease candidates. The trial approval is pending from the local Ethics Committee and the New Zealand Medicines and Medical Devices Safety Authority.